Acupuncture Vs Streitberger Needle in Knee Osteoarthritis – An Rct

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 15-24 ◽  
Author(s):  
Jorge Vas ◽  
Camila Méndez ◽  
Emilio Perea-Milla

Aims To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. Methods Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. Results Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. Conclusions The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.


2018 ◽  
Vol 23 (4) ◽  
pp. 199-207 ◽  
Author(s):  
Ilyoung Cho ◽  
Hyun-Min Lee ◽  
Sung-Won Choi ◽  
Soo-Keun Kong ◽  
Il-Woo Lee ◽  
...  

Objectives: This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis. Methods: Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol. Results: A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038). Conclusion: These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.


Gut ◽  
2020 ◽  
pp. gutjnl-2020-321996
Author(s):  
Takahisa Matsuda ◽  
Takahiro Fujii ◽  
Yasushi Sano ◽  
Shin-ei Kudo ◽  
Yasushi Oda ◽  
...  

ObjectiveTo assess whether follow-up colonoscopy after polypectomy at 3 years only, or at 1 and 3 years would effectively detect advanced neoplasia (AN), including nonpolypoid colorectal neoplasms (NP-CRNs).DesignA prospective multicentre randomised controlled trial was conducted in 11 Japanese institutions. The enrolled participants underwent a two-round baseline colonoscopy (interval: 1 year) to remove all neoplastic lesions. Subsequently, they were randomly assigned to undergo follow-up colonoscopy at 1 and 3 years (2-examination group) or at 3 years only (1-examination group). The incidence of AN, defined as lesions with low-grade dysplasia ≥10 mm, high-grade dysplasia or invasive cancer, at follow-up colonoscopy was evaluated.ResultsA total of 3926 patients were enrolled in this study. The mean age was 57.3 (range: 40–69) years, and 2440 (62%) were male. Of these, 2166 patients were assigned to two groups (2-examination: 1087, 1-examination: 1079). Overall, we detected 29 AN in 28 patients at follow-up colonoscopy in both groups. On per-protocol analysis (701 in 2-examination vs 763 in 1-examination group), the incidence of AN was similar between the two groups (1.7% vs 2.1%, p=0.599). The results of the non-inferiority test were significant (p=0.017 in per-protocol, p=0.001 in intention-to-treat analysis). NP-CRNs composed of dominantly of the detected AN (62%, 18/29), and most of them were classified into laterally spreading tumour non-granular type (83%, 15/18).ConclusionAfter a two-round baseline colonoscopy, follow-up colonoscopy at 3 years detected AN, including NP-CRNs, as effectively as follow-up colonoscopies performed after 1 and 3 years.


2018 ◽  
Vol 89 (9) ◽  
pp. 970-976 ◽  
Author(s):  
Jana Pöttgen ◽  
Rona Moss-Morris ◽  
Janina-Maria Wendebourg ◽  
Lena Feddersen ◽  
Stefanie Lau ◽  
...  

ObjectiveFatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited.Here, we tested the effectiveness of a self-guided , interactive, online fatigue management programme (ELEVIDA) based on principles of cognitive behavioural therapy (CBT) and related psychotherapeutic approaches (eg, mindfulness) for reducing fatigue in MS.MethodsPatients with MS and self-reported fatigue were recruited via the website of the German MS Society and assigned via an automated randomisation generator (1:1, no blocking or stratification) to a 12-week online intervention (ELEVIDA, n=139, 82% female, mean age 40.8, median patient determined disease steps (PDDS) 3.0) or a waitlist control group (n=136, 79% female, mean age 41.9, median PDDS 3.0). The primary outcome was the Chalder Fatigue Scale. Outcomes were assessed at baseline, at week 12 (postintervention) and at follow-up (week 24).ResultsCompared with the control group, significantly greater reductions in Chalder Fatigue Scale scores were seen in the ELEVIDA group at week 12 (primary endpoint, intention-to-treat analysis: between-group mean difference 2.74 points; 95% CI 1.16 to 4.32; p=0.0007; effect size d=0.53), with effects sustained at week 24 (intention-to-treat analysis: between-group mean difference 2.19 points; 95% CI 0.57 to 3.82; p=0.0080).ConclusionsOur trial provides evidence for the effectiveness of a self-guided , internet-based intervention to reduce fatigue in MS. Interventions such as ELEVIDA may be a suitable low barrier, cost-effective treatment option for MS fatigue.Trial registration numberISRCTN registry (number ISRCTN25692173).


2020 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Khaled Cheha

Abstract Background: The eradication rate of Helicobacter Pylori infection with standard triple therapy either clarithromycin or levofloxacin has declined due to antimicrobial resistance. The aim of this research was to estimate the eradication rate of bismuth quadruple and levofloxacin concomitant regimens as empirical first-line regimens in a referral hospital in Syria.Settings and Design: an open‑label parallel blind randomized controlled trial.Methods: Researchers randomly assigned naïve patients with H pylori infection with a 1:1 ratio into two groups. We give group A (bismuth subsalicylate 524 mg four times a day, and doxycycline 100 mg tinidazole 500 mg and esomeprazole 20 mg, each twice daily for 14 days). We give group B (levofloxacin 500 mg every day, tinidazole 500 mg, amoxicillin 1000 mg and esomeprazole 20 mg each twice daily for 14 days). Researchers used a computer program to generate randomized numbers. We concealed the sequence in an opaque envelope until the intervention was assigned. medical laboratory doctors were blinded to treatment allocation. Statistical analysis: chi-square test for categorical variables, t-test for continuous data.Results: Researchers allocated seventy-eight patients. Thirty-eight patients completed the follow‑up in bismuth regimen, and thirty-nine patients in concomitant levofloxacin. Thirty patients in the bismuth regimen were cured, the eradication rate was 78.94% according to per-protocol analysis, and 76.92% according to intention‑to‑treat analysis. While in concomitant levofloxacin thirty-two patients were cured, the eradication rate was 82.05% according to intention‑to‑treat analysis (P = 0.780). Researchers didn’t report serious adverse events in both groups. Odds ratio with 95% confidence interval according to the intention‑to‑treat analysis was 1.371 [0.454-4.146]. While the odds ratio with a 95% confidence interval according to per-protocol analysis was 1.22 [0.394-3.774].Conclusions: Both treatment regimens had acceptable eradication rates. Researchers suggest using both regimens as empirical first-line therapy in treating Helicobacter Pylori gastric infection in the Syrian population. No serious adverse events were recorded.Trial registration: Researchers This study was registered as a standard randomized clinical trial (Clinicaltrial.gov, identifier‑NCT04348786, date:29-January-2020, https://clinicaltrials.gov/ct2/show/NCT04348786).


Lupus ◽  
2019 ◽  
Vol 28 (11) ◽  
pp. 1368-1377
Author(s):  
M Oliveira-Santos ◽  
J F S Verani ◽  
L A B Camacho ◽  
C A F de Andrade ◽  
E M Klumb

Objective Studies have been conducted to determine the causal factors and clinical consequences of non-adherence to treatment in systemic lupus erythematosus (SLE). However, no interventions have been performed to increase drug adherence. Our objective was to assess the effectiveness of pharmaceutical care (PC) for drug treatment adherence in lupus nephritis (LN). Methods This was a randomized clinical trial (pragmatic trial) in patients with LN in Rio de Janeiro, Brazil, allocated in two groups: an intervention group (Dader Method for PC) and a control group (institution's usual care). Drug treatment adherence was measured by the combination of five questions normally used in clinical practice. Results A total of 131 patients were randomized, and 122 completed the study, with a mean follow-up of 12.7 months and use of six drugs per day and 10–12 doses per day. Low adherence was observed at baseline (intervention group: 30%; control group: 29%). PC showed 27% effectiveness (95% confidence interval (CI) –6% to 50%) in the intention to treat analysis and 31% (95% CI 0–52%) in per protocol analysis, considering all drugs. As for adherence to specific drugs for SLE, effectiveness of PC was 64% (95% CI 34–80%) with intention-to-treat analysis and 62% (95% CI 32–79%) in per protocol analysis. Conclusions PC was effective for increasing drug treatment adherence in SLE. The detailed account provided by the Dader Method of the difficulties with patients' drug therapy proved invaluable to approach non-adherence.


2021 ◽  
Author(s):  
Xiaoying Zhou ◽  
Han Chen ◽  
Meihong Chen ◽  
Chao Ding ◽  
Guoxin Zhang ◽  
...  

Abstract Background: Widespread endoscopic submucosal dissection (ESD) in early esophageal cancer patients is closely associated with esophageal stricture, which dramatically reduces patients’ quality of life and increases huge medical burdens. Endoscopic injection of steroid was proved as a protective method for post-ESD strictures. Other materials such as botulinum toxin type A (BTX-A) may be potential candidates. We conducted this prospective cohort study to compare the efficacy and feasibility of endoscopic injection of BTX-A and triamcinolone acetonide (TA) for the prevention of esophageal stricture.Methods: Seventy-eight patients with esophageal mucosal defects of more than two thirds of the circumference were successively enrolled and divided into 3 groups: BTX-A group (group A, n=26), TA group (group B, n=16) and control group (group C, n=36). Patients in group A were immediately injected with BTX-A after ESD, in group B were immediately injected with TA and in group C received ESD only. Endoscopy was performed when patients reported dysphagia symptoms and at 6 and 12 weeks post-ESD in patients without symptoms. Patients who experienced post-ESD esophageal strictures in all groups received bougie dilation. All patients were followed up for one year.Results: The proportion of patients developing stricture in BTX-A group was 30.00% (intention to treat analysis, 9/30) and 26.92% (per protocol analysis, 7/26), in TA group was 40.90% (intention to treat analysis, 9/22) and 43.75% (per protocol analysis, 7/16), and in control group was 84.21% (intention to treat analysis, 32/38) and 83.33% (per protocol analysis, 30/36) (p<0.001). When further comparing between each of the two groups, the incidence of esophageal stricture was lower in BTX-A group than that in control group (p<0.001), and lower in TA group than that in control group (p=0.004). Furthermore, in entire circumference mucosal defect subgroup, the esophageal stricture was significantly lower in BTX-A group than that in TA group (33.3% vs 100%, p=0.0454).Conclusions: Endoscopic injection of BTX-A and TA were effective in preventing post-ESD esophageal strictures and BTX-A injection was particularly effective in entire circumference mucosal defect patients. Multi-centered, randomized prospective study with larger sample size should be conducted. (Clinical trial registration number: ChiCTR2100042970, registered 1 February 2021, retrospectively registered, http://www.chictr.org.cn/listbycreater.aspx)


2021 ◽  
pp. 037957212110254
Author(s):  
Sylvester O. Ojwang ◽  
David J. Otieno ◽  
Julius J. Okello ◽  
Penina Muoki ◽  
Rose A. Nyikal

Background: Biofortified staples have been promoted widely in sub-Saharan Africa to combat micronutrient deficiencies. Contemporary projects are increasingly using elementary schools to target households with these foods. Objective: This study assessed the effects of integrated nutrition education approaches, targeting preschoolers and their caregivers, on retention of orange-fleshed sweetpotato (OFSP) on farms in the second season after lapse of free vine dissemination initiatives. Methods: Rural farming households, with preschoolers and no prior engagement with OFSP, were targeted. A multistage sample of 431 preschooler–caregiver pairs was recruited for a cluster-randomized controlled trial. After issuing routine OFSP promotion activities, 15 village-level clusters of the pairs were randomized into 1 control group (3 villages) and 3 treatment arms (4 villages each) for the interventions. Baseline and follow-up household-level survey data were collected from the caregivers. The interventions included: (1) OFSP-branded exercise books, posters, and a poem to preschoolers only; (2) OFSP-oriented mobile phone-mediated text messages to caregivers only; and (3) both 1 and 2 provided to individual households concurrently. Interventions 1 and 2 were single-channeled, while 3 was multichanneled. We estimated the intention-to-treat (ITT) and treatment-on-the-treated (TOT) effects using a binary logit model and a special regressor method, respectively. Results: Only the multichanneled nutrition education approach had significant effects (ITT = 0.167, P = .001; TOT = .243, P = .007) on the caregivers’ likelihood to retain OFSP on their farms. Conclusions: The finding implies that multichanneled agriculture-nutrition education interventions through Early Childhood Development institutions can be effective in ensuring sustainable adoption of OFSP.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Urška Nabergoj Makovec ◽  
Igor Locatelli ◽  
Mitja Kos

Abstract Background Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. Methods A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. Results Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16–2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05–1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = − 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. Conclusion MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. Trial registration ClinicalTrials.gov - NCT04417400; 4th June 2020; retrospectively registered.


Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.


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